Installation Qualification (IQ) Protocol for [Equipment Name/Model]
Semi-Solid Tube Filler
Document Title: Installation Qualification (IQ) Protocol for [Equipment
Name/Model] Semi-Solid Tube Filler
Document Number: [e.g., IQ-TF-XXX-YYY]
Version: [e.g., 1.0]
Effective Date: [DD-MMM-YYYY]
Approvals:
[Preparer Name, Title, Signature, Date]
[Reviewer 1 Name, Title, Signature, Date]
[Reviewer 2 Name, Title, Signature, Date]
[QA Approval Name, Title, Signature, Date]
1. Purpose
The purpose of this Installation Qualification (IQ) protocol is to verify and
document that the [Equipment Name/Model] Semi-Solid Tube Filler has
been received, installed, and configured according to the manufacturer's
specifications, approved design documents (DQ), and all relevant User
Requirement Specifications (URS), regulatory requirements (e.g., cGMP), and
internal company standards.
2. Scope
This IQ protocol applies to the physical installation and initial setup of the
[Equipment Name/Model] Semi-Solid Tube Filler, including its main
components, utility connections, and associated hardware located at
[Specific Location/Room Number].
This IQ covers, but is not limited to, the following aspects:
Receipt and inspection of the equipment.
Verification of proper placement and leveling.
Confirmation of correct utility connections (electrical, compressed air,
water, etc.).
Verification of component installation as per vendor documentation.
Calibration of critical instruments (if performed during IQ).
Documentation verification (manuals, drawings, certifications).
Safety feature verification.
This IQ does NOT cover:
Functional testing of the equipment (covered in OQ).
Performance testing with product (covered in PQ).
3. References
User Requirement Specification (URS) for Semi-Solid Tube Filler
[Document Number]
Design Qualification (DQ) Protocol for [Equipment Name/Model] Semi-
Solid Tube Filler [Document Number]
Manufacturer's Installation Manual for [Equipment Name/Model]
Manufacturer's Operation and Maintenance Manual for [Equipment
Name/Model]
Vendor's Technical Specifications/Drawings [Document Number]
Approved P&ID (Piping and Instrumentation Diagram) [Document
Number]
Approved Electrical Schematics [Document Number]
Company Standard Operating Procedures (SOPs) for Equipment
Qualification, Calibration, Maintenance, etc.
cGMP Regulations (e.g., 21 CFR Part 210, 211, EudraLex Volume 4)
[Any relevant local codes/standards, e.g., electrical safety standards]
4. Responsibilities
Project Manager: Overall oversight of the IQ process.
Engineering/Technical Lead: Responsible for executing the IQ
protocol, coordinating with the vendor, and documenting results.
User Department (e.g., Production/Operations): To provide
operational input and verify suitability of installation for routine use.
Quality Assurance (QA): Responsible for review and approval of the
IQ protocol and final report, ensuring compliance with quality systems
and regulatory requirements.
Vendor/Supplier: To provide technical support during installation and
supply necessary documentation.
Calibration Technician: For performing and documenting calibrations
of instruments as required.
5. Equipment Identification
Equipment Type: Automatic Semi-Solid Tube Filler
Manufacturer: [Vendor Name]
Model Number: [Model Number]
Serial Number(s): [List all relevant serial numbers for main unit and
critical components]
Asset Number: [Company Asset Tag]
Location: [Building/Room Number]
6. Prerequisites
Ensure all the following conditions are met before commencing the IQ
activities:
DQ protocol is approved and all critical DQ deviations are resolved.
Equipment has been received, uncrating and preliminary visual
inspection completed.
Area for installation is prepared, clean, and meets environmental
requirements.
Required utilities (power, compressed air, water, etc.) are available at
the installation point and meet specified quality.
All necessary personnel are trained on this IQ protocol and relevant
SOPs.
All required tools, calibration equipment, and safety gear are available.
7. IQ Test Plan and Acceptance Criteria
Each section below outlines specific checks to be performed. Document the
results for each check as "Pass," "Fail," or "N/A" (Not Applicable) and provide
comments/deviations as necessary.
7.1. Documentation Verification
Result
Chec Description of Acceptanc Comments/
(P/F/N/A
k No. Check e Criteria Reference Doc. No.
)
Manual
Verify receipt of
received
Manufacturer's
7.1.1 and
Installation
version
Manual.
noted.
Verify receipt of Manual
Manufacturer's received
7.1.2 Operation & and
Maintenance version
Manual. noted.
Schematic
Verify receipt of
s received
7.1.3 Electrical
and
Schematics.
current.
7.1.4 Verify receipt of P&ID
P&ID drawings (if received
Result
Chec Description of Acceptanc Comments/
(P/F/N/A
k No. Check e Criteria Reference Doc. No.
)
and
applicable).
current.
BOM
received
Verify receipt of
and
7.1.5 Bill of Materials
componen
(BOM).
t lists
complete.
Verify receipt of
Certificate
Material
s for
Certificates (e.g.,
7.1.6 critical
3.1 for SS316L for
MOC
product contact
received.
parts).
Verify receipt of
Certificate
Welder
s received
Qualification
7.1.7 for
Certificates (for
relevant
product contact
welders.
parts).
Verify receipt of
Welding
WPS/PQR
Procedure
document
7.1.8 Specifications
s
(WPS/PQR) for
received.
product contact
parts.
7.1.9 Verify receipt of Manual
Result
Chec Description of Acceptanc Comments/
(P/F/N/A
k No. Check e Criteria Reference Doc. No.
)
received
Software User
and
Manual/Descriptio
version
n.
noted.
Verify receipt of
Certificate
Calibration
s received
7.1.1 Certificates for
and valid
0 manufacturer-
dates
installed
confirmed.
instruments.
7.1.1 Verify receipt of List
1 spare parts list. received.
7.2. Physical Installation Verification
Result
Check Description of Acceptanc Comments/
(P/F/N/A
No. Check e Criteria Reference Doc. No.
)
Verify equipment
model and serial Matches
7.2.1 number match PO and
Purchase Order DQ.
and DQ.
Verify equipment
is placed in Correct
7.2.2 designated placement
location as per .
layout drawings.
Result
Check Description of Acceptanc Comments/
(P/F/N/A
No. Check e Criteria Reference Doc. No.
)
Verify equipment
is leveled and
Level and
7.2.3 securely
secure.
anchored (if
required).
Verify all shipping
restraints/packagi
All
7.2.4 ng materials
removed.
have been
removed.
Verify general
Clean and
cleanliness of the
7.2.5 free of
equipment after
debris.
installation.
7.3. Utility Connections Verification
Result Comments/
Chec Description of Acceptance
(P/F/N/ Reference Doc.
k No. Check Criteria
A) No.
Verify electrical
supply voltage
Correct
and frequency
7.3.1 voltage/freque
match
ncy.
equipment
requirements.
7.3.2 Verify proper Properly
grounding/eart grounded.
hing of the
Result Comments/
Chec Description of Acceptance
(P/F/N/ Reference Doc.
k No. Check Criteria
A) No.
equipment.
Verify
compressed air
supply
Correct
pressure and
7.3.3 pressure/qualit
quality (e.g.,
y.
dew point, oil-
free) meet
specifications.
Verify utility
connections
(water, steam,
nitrogen if Correct
7.3.4
applicable) are connections.
correctly
identified and
connected.
Verify all utility
All lines
7.3.5 lines are
labeled.
clearly labeled.
7.4. Component Installation Verification
Result
Check Description of Acceptance Comments/
(P/F/N/A
No. Check Criteria Reference Doc. No.
)
7.4.1 Verify all major All
components components
(e.g., tube installed.
feeder, filling
Result
Check Description of Acceptance Comments/
(P/F/N/A
No. Check Criteria Reference Doc. No.
)
pump, sealing
head) are
installed as
per GADs.
Verify material
of construction
(MOC) for
product
contact parts MOC
7.4.2
matches DQ verified.
and URS
(visual check
and document
reference).
Verify surface
finish of
Acceptable
product
7.4.3 surface
contact parts
finish.
(visual
inspection).
7.4.4 Verify No visible
absence of dead
dead legs legs/crevice
and crevices s.
on product
contact
surfaces
(visual
inspection,
weld
Result
Check Description of Acceptance Comments/
(P/F/N/A
No. Check Criteria Reference Doc. No.
)
inspection).
Verify correct
installation of
all sensors, Correct
7.4.5
limit switches, installation.
and safety
interlocks.
Verify proper
sealing of all
Properly
7.4.6 electrical
sealed.
enclosures and
control panels.
7.5. Calibration Verification (if applicable during IQ)
For critical instruments that are installed and require calibration prior to
operation. If calibrations are performed by a separate department/vendor,
verify their certificates here.
Calibration
Check Acceptance Result
Description of Check Certificate
No. Criteria (P/F/N/A)
No./Date
Verify pressure
gauges are Valid
7.5.1
calibrated and in calibration.
range.
Verify temperature
sensors are Valid
7.5.2
calibrated and in calibration.
range.
Calibration
Check Acceptance Result
Description of Check Certificate
No. Criteria (P/F/N/A)
No./Date
Verify flow meters
Valid
7.5.3 are calibrated and in
calibration.
range.
Verify load cells (if
applicable to filling Valid
7.5.4
accuracy calibration.
measurement).
Verify machine Valid
7.5.5
speed indicator. calibration.
7.6. Safety Feature Verification (Initial Check)
Check Acceptance Result Comment
Description of Check
No. Criteria (P/F/N/A) s
Verify all Emergency
Stop (E-Stop) buttons Clear and
7.6.1
are clearly labeled and accessible.
accessible.
Verify physical
Guards
7.6.2 guarding is in place
secure.
and secured.
Verify safety interlocks
on access doors/guards Present and
7.6.3 are present and appear appear
functional (full functional.
functional test in OQ).
7.6.4 Verify audible/visual Present.
Check Acceptance Result Comment
Description of Check
No. Criteria (P/F/N/A) s
alarms are present.
8. Deviations and Resolution
Document any deviations identified during the IQ execution. All "Fail" results
must be documented as a deviation and resolved before IQ completion.
Descr Verifi
Impact on Propo Tar Status
Devi iption Respo catio
Compliance/ sed get (Open/
ation of nsibilit n of
Functionalit Resol Da Closed
ID Devia y Resol
y ution te )
tion ution
Electr
ical
Secur
cable DD
e
for -
cable Visual
IQ- moto Potential M
with Engine verifi
DEV- r X is safety M Closed
appro ering catio
001 not hazard. M-
priate n.
prope YY
cable
rly YY
ties.
secur
ed.
... ... ... ... ... ... ... ...
9. Conclusion and Recommendation
Summarize the results of the IQ protocol, stating whether all
acceptance criteria have been met and all deviations have been
resolved.
Provide a clear recommendation for proceeding to the next
qualification stage (Operational Qualification - OQ).
Statement:
"Based on the successful completion of all tests outlined in this Installation
Qualification Protocol and the satisfactory resolution of all identified
deviations, the [Equipment Name/Model] Semi-Solid Tube Filler, Serial
Number [Serial Number], is deemed to be installed in accordance with
manufacturer's specifications, approved design documentation, and
applicable regulatory requirements.
It is hereby recommended to proceed with Operational Qualification (OQ)
activities for this equipment."
10. Appendices (if applicable)
As-Built Drawings (if deviations from design drawings occurred)
Completed Calibration Certificates (if performed during IQ)
Photographs of installation (e.g., showing utility connections, MOC,
weld quality)
Vendor's Installation Checklist (if provided and completed)
Guidance for Filling out the Template:
Be Specific: Do not use generic statements. Provide specific details,
measurements, and references.
Documentation: Every check should be backed by documented
evidence (e.g., serial numbers, photos, measurements, signed
checklists).
Signature & Date: Ensure all checks are signed and dated by the
person performing the check.
Controlled Document: This protocol and its completed report must
be controlled documents within your quality management system.
Traceability: Maintain traceability between the URS, DQ, IQ, OQ, and
PQ documents.
Do you have any specific areas of the IQ you'd like to delve into further,
perhaps regarding the details of certain checks?
